FDA WARNING_LETTER - Apollo Care, LLC - March 27, 2025

On February 2, 2026, the FDA issued a Warning Letter to Apollo Care, LLC, following an inspection of its Columbia, Missouri facility conducted from March 10 to March 27, 2025. The agency identified serious violations of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically regarding Current Good Manufacturing Practice (CGMP) and the maintenance of sanitary conditions for sterile drug production. Main issues included improper sanitization practices near exposed drug solutions, failure to respond adequately to microbial contamination in sterile areas, and the presence of foreign debris in cleanrooms. Additionally, the facility utilized textured wall surfaces that are difficult to clean and failed to provide validated evidence, such as comprehensive smoke studies, to ensure sterile airflow. While Apollo Care initiated a voluntary recall of certain Fentanyl and Ropivacaine lots in April 2025, the FDA found their subsequent corrective actions insufficient or contradictory. The regulatory framework cited involves Sections 503B, 501(a)(2)(A), and 501(a)(2)(B) of the FDCA. The FDA requires Apollo Care to hire a third-party consultant to perform a comprehensive assessment of their operations and facility design. The company must submit a written response within 15 working days detailing specific corrective actions and preventive measures to ensure future compliance. Failure to address these deficiencies may result in legal action, including product seizures or injunctions.